Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-01 @ 9:47 AM
Study NCT ID:
NCT00920556
Status:
TERMINATED
Last Update Posted:
2019-02-27
First Post:
2009-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination With Bortezomib in Patients With Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077185', 'term': 'Resveratrol'}, {'id': 'D000069286', 'term': 'Bortezomib'}], 'ancestors': [{'id': 'D000081225', 'term': 'Stilbestrols'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D059808', 'term': 'Polyphenols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study of Multiple Myeloma, was terminated early due to minimal efficacy signal observed.'}}, 'adverseEventsModule': {'timeFrame': 'From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)', 'description': 'SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.', 'eventGroups': [{'id': 'EG000', 'title': 'SRT501', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. No administration of SRT501, will occur on Day 21 of each cycle.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 2, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DISEASE PROGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'LETHARGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'MUSCULOSKELETAL CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'JOINT SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'NECK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PHARYNGOLARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PRODUCTIVE COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'RHINORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ANOREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ORAL CANDIDIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CONFUSIONAL STATE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'RENAL FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'RENAL IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neutropenic sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately up to 12 cycles of 3 weeks each', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population was defined as all the participants who received any amount of SRT501 or bortezomib.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately up to 12 cycles of 3 weeks', 'description': 'Overall response rate, defines proportion of participants with Complete response (CR), Partial response (PR) or Minimal response (MR) as best response for all cycles. In atleast 2 determinations for minimum of 6 week (Wks) for every criteria listed. CR defined as disappearance of original monoclonal (MC) paraprotein (PP) in blood and urine on immunofixation determinations (IFD); \\< 5 % plasma cells in bone marrow; no increase in size or number of lytic bone lesions (LBLs); disappearance of soft tissue plasmacytomas (STP). PR defined as \\>= 50% reduction (RE) in level of serum MC PP for 2 IFDs; if present RE in 24 hour urinary light chain excretion (ULCE) by \\>= 90% RE or \\<200 mg; \\>= 50% RE in STP for; no increase in size or number of LBLs. MR criteria defined were \\>= 25% to \\<=49% RE serum MC PP; if present 50 to 89% RE in 24 hour LCE exceeding 200 mg/24 hour; 25% to 49% RE in size of STP; no increase in size or number of LBLs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (mITT), had participants who completed first (2) cycles of SRT501 monotherapy. Participants dropped were not counted; those withdrew after 2nd cycle were considered evaluable regardless of discontinuation reason; alongwith participants discontinued for missing clinical trial material after 2 cycle, were considered.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Partial Response (PR) as Best Response (BR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 cycles of 3 weeks each', 'description': 'PR includes some, but not all, criteria for CR providing the remaining criteria are satisfied: ≥50% reduction in the level of serum monoclonal paraprotein for at least 2 immunofixation determinations for a minimum of 6 weeks, If present, reduction in 24 hr urinary light chain excretion by either ≥90% or to \\<200 mg for at least 2 determinations for a minimum of 6 weeks, ≥50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for a minimum of 6 weeks, No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Minor Response (MR) as Best Response (BR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 cycles of 3 weeks each', 'description': 'MR includes some, but not all, criteria for PR providing the remaining criteria satisfied: ≥25% to ≤ 49% reduction in the level of serum monoclonal paraprotein for at least 2 immunofixation determinations for a minimum of 6 weeks, If present, a 50 to 89% reduction in 24 hr light chain excretion, which still exceeds 200 mg/24 hr, for at least 2 determinations for a minimum of 6 weeks, 25-49% reduction in the size of plasmacytomas (by clinical or radiographic examination) for a minimum of 6 weeks, No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Partial Response (PR) as Last Observed Response (LOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 cycles of 3 weeks each', 'description': 'PR includes some, but not all, criteria for CR providing the remaining criteria are satisfied: ≥50% reduction in the level of serum monoclonal paraprotein for at least 2 immunofixation determinations for a minimum of 6 weeks, If present, reduction in 24 hr urinary light chain excretion by either ≥90% or to \\<200 mg for at least 2 determinations for a minimum of 6 weeks, ≥50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for a minimum of 6 weeks, No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Stable Disease (SD) as Best Response (BR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 cycles of 3 weeks each', 'description': 'Stable disease included not meeting the criteria for MR or PD.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Stable Disease (SD) as Last Observed Response (LOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 cycles of 3 weeks each', 'description': 'Stable disease included not meeting the criteria for MR or PD.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Progressive Disease (PD) PD as Best Response (BR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 cycles of 3 weeks each', 'description': 'PD includes one or more of the following criteria: \\>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation, \\>25% increase in 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 hr and confirmed on a repeat investigation, \\>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%., Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas, Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture), Development of hypercalcemia (corrected serum calcium \\>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Progressive Disease (PD) PD as Last Observed Response (LOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 cycles of 3 weeks each', 'description': 'PD includes one or more of the following criteria: \\>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation, \\>25% increase in 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 hr and confirmed on a repeat investigation, \\>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%., Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas, Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture), Development of hypercalcemia (corrected serum calcium \\>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population.'}, {'type': 'PRIMARY', 'title': 'Time to Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '2.8'}, {'value': '2.8', 'comment': "NA indicates 'Q3 is not evaluable' as less than 75th percentile of participants reported disease progression.", 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 till disease progression (approximately 12 cycles of 3 weeks each)', 'description': 'Time to disease progression was defined as the time from first dose until objective tumor progression. Participants who did not experience tumor progression were censored at their last known date in the study. It was estimated using Kaplan-Meier methodology. Participants who did not experience tumor progression were censored at their last known date in the study. The first quartile for time to disease progression was evaluated when 25th percentile of participants of mITT population reported disease progression. Similarly, median and 75th percentile of participants of MITT population was planned to be reported. If, less than 75th percentile of participants reported disease progression at the end of the study period, then the observation was censored for the purpose of this analysis and in such case the data was planned to be reported as not evaluable (NA).', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Only those participants available at the specified timepoints were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hematology: White Blood Cell (WBC) Count, Neutrophils, Lymphocytes, Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'title': 'WBC count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.55', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.27', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '1.46', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.1', 'spread': '58.1', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '66.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)', 'description': 'Blood samples collected to evaluate the hematology parameters were WBC count, neutrophils, lymphocytes and platelets. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.', 'unitOfMeasure': '10^9 cells per liter (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified timepoints were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hematology: Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)', 'description': 'Blood samples were collected to evaluate the hematology parameter hematocrit. Change from Baseline was defined as the value of baseline minus from the End of study visit. Baseline was defined as Day 1.', 'unitOfMeasure': 'Proportion of red blood cells in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Only those participants available at the specified time-points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hematology: Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '-11.4', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '-9.17', 'spread': '14.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)', 'description': 'Blood samples were collected to evaluate the hematology parameter hemoglobin. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.', 'unitOfMeasure': 'Gram per litre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Only those participants available at the specified timepoints were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hematology: Red Blood Cell (RBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)', 'description': 'Blood samples were collected to evaluate the hematology parameter RBC. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.', 'unitOfMeasure': '10^12 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From in Baseline Biochemistry: Serum Creatinine, Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'title': 'Serum creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.8', 'spread': '123.5', 'groupId': 'OG000'}, {'value': '3.60', 'spread': '8.41', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '5.65', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '2.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)', 'description': 'Blood samples were collected to evaluate hematology parameters serum creatinine and total bilirubin. Change from Baseline was defined as the value of baseline minus from the End of study visit. Baseline was defined as Day 1.', 'unitOfMeasure': 'Micromole per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Biochemistry -Urea, Bicarbonate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, orally every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'title': 'Bicarbonate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.81', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.50', 'spread': '7.87', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '1.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)', 'description': 'Blood samples were collected to evaluate the biochemistry parameter urea and bicarbonate. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.', 'unitOfMeasure': 'millimole per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Biochemistry: Prothrombin Time (PT)/ International Normalized Ratio (INR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care.SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)', 'description': 'Blood samples were collected to evaluate the biochemistry parameter PT/INR. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.', 'unitOfMeasure': 'Ratio of PT/INR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the particular timepoints were analyzed'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of SRT501 at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SRT501 Monotherapy', 'description': 'The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. No administration of SRT501, will occur on Day 21 of each cycle.'}, {'id': 'OG001', 'title': 'SRT501 + Bortezomib', 'description': "The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy."}], 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 2 and Cycle 1 Day 20 at pre-dose, 30 minute, 1 hour, 2 hour, 4 hour, 6 hour and 24 hour post-dose. Day 2 and Day 20, samples collected post-dose. Each cycle duration was 21 days.', 'description': 'Pharmacokinetic sampling on Day1/2 and Day 20/21 of Cycle 1 for participants ready to participate was planned. The sampling was planned to be collected at timepoints on Cycle 1 Day 1 at pre-dose, 30 minute, 1 hour, 2 hour, 4 hour, 6 hour and 24 hour post-dose and the same timepoints on Day 2 and Day 20 post- dose. It was to be collected in participants who fasted atleast for an hour. Due to early termination of the study, the data for Pharmacokinetic analysis was not collected.', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who receive study drug and have adequate pharmacokinetic data available will be included in the pharmacokinetics population, with data summarized by dose group. Data not collected due to early termination of the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Study', 'description': 'Eligible participants were administered 5 gram (g) of SRT501, as oral suspension every morning approximately 15-30 minutes after breakfast), for 20 days in 21-day cycle, for max period of 12 cycles (Not administered on Day 21 of each cycle). Post first two cycles, participant who exhibited stable disease (SD) or better, with SRT501 monotherapy, continued for additional two cycles. If, after first 2 cycles, participant exhibited PD, then received bortezomib (1.3 milligram(mg)/meter square (m\\^2)on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) along with SRT501. Bortezomib was administered intravenous suspension, prior to breakfast and SRT501 administration. If after 2 additional cycles of SRT501 monotherapy (4 cycles total), participant exhibited SD or better, they remained on SRT501 therapy, until judged to have PD. If PD,participants underwent bortezomib regiment as above. At any point of (SRT501+Bortezoimb),participant was assessed with PD, was discontinued'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 24 participants with Multiple Myeloma were enrolled in the study. The study was conducted at four centers in United Kingdom and 1 center in Denmark, and was terminated early.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Eligible participants were administered 5 gram (g) of SRT501, as oral suspension every morning approximately 15-30 minutes after breakfast), for 20 days in 21-day cycle, for max period of 12 cycles (Not administered on Day 21 of each cycle). Post first two cycles, participant who exhibited stable disease (SD) or better, with SRT501 monotherapy, continued for additional two cycles. If, after first 2 cycles, participant exhibited progressive disease (PD), then received bortezomib (1.3 milligram(mg)/meter square (m\\^2)on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) along with SRT501. Bortezomib was administered intravenous suspension, prior to breakfast and SRT501 administration. If after 2 additional cycles of SRT501 monotherapy (4 cycles total), participant exhibited SD or better, they remained on SRT501 therapy, until judged to have PD. If PD,participants underwent bortezomib regiment as above. At any point of (SRT501+Bortezoimb),participant was assessed with PD, was discontinued'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '7.83', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Afro-Caribbean', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Caucasian', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'Study terminated.24 subjects enrolled;provided adequate data for decision making.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2010-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-17', 'studyFirstSubmitDate': '2009-06-12', 'resultsFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2009-06-12', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-17', 'studyFirstPostDateStruct': {'date': '2009-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Approximately up to 12 cycles of 3 weeks each', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.'}, {'measure': 'Number of Participants With Overall Response Rate', 'timeFrame': 'Approximately up to 12 cycles of 3 weeks', 'description': 'Overall response rate, defines proportion of participants with Complete response (CR), Partial response (PR) or Minimal response (MR) as best response for all cycles. In atleast 2 determinations for minimum of 6 week (Wks) for every criteria listed. CR defined as disappearance of original monoclonal (MC) paraprotein (PP) in blood and urine on immunofixation determinations (IFD); \\< 5 % plasma cells in bone marrow; no increase in size or number of lytic bone lesions (LBLs); disappearance of soft tissue plasmacytomas (STP). PR defined as \\>= 50% reduction (RE) in level of serum MC PP for 2 IFDs; if present RE in 24 hour urinary light chain excretion (ULCE) by \\>= 90% RE or \\<200 mg; \\>= 50% RE in STP for; no increase in size or number of LBLs. MR criteria defined were \\>= 25% to \\<=49% RE serum MC PP; if present 50 to 89% RE in 24 hour LCE exceeding 200 mg/24 hour; 25% to 49% RE in size of STP; no increase in size or number of LBLs.'}, {'measure': 'Number of Participants With Partial Response (PR) as Best Response (BR)', 'timeFrame': 'Up to 12 cycles of 3 weeks each', 'description': 'PR includes some, but not all, criteria for CR providing the remaining criteria are satisfied: ≥50% reduction in the level of serum monoclonal paraprotein for at least 2 immunofixation determinations for a minimum of 6 weeks, If present, reduction in 24 hr urinary light chain excretion by either ≥90% or to \\<200 mg for at least 2 determinations for a minimum of 6 weeks, ≥50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for a minimum of 6 weeks, No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).'}, {'measure': 'Number of Participants With Minor Response (MR) as Best Response (BR)', 'timeFrame': 'Up to 12 cycles of 3 weeks each', 'description': 'MR includes some, but not all, criteria for PR providing the remaining criteria satisfied: ≥25% to ≤ 49% reduction in the level of serum monoclonal paraprotein for at least 2 immunofixation determinations for a minimum of 6 weeks, If present, a 50 to 89% reduction in 24 hr light chain excretion, which still exceeds 200 mg/24 hr, for at least 2 determinations for a minimum of 6 weeks, 25-49% reduction in the size of plasmacytomas (by clinical or radiographic examination) for a minimum of 6 weeks, No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).'}, {'measure': 'Number of Participants With Partial Response (PR) as Last Observed Response (LOR)', 'timeFrame': 'Up to 12 cycles of 3 weeks each', 'description': 'PR includes some, but not all, criteria for CR providing the remaining criteria are satisfied: ≥50% reduction in the level of serum monoclonal paraprotein for at least 2 immunofixation determinations for a minimum of 6 weeks, If present, reduction in 24 hr urinary light chain excretion by either ≥90% or to \\<200 mg for at least 2 determinations for a minimum of 6 weeks, ≥50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for a minimum of 6 weeks, No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).'}, {'measure': 'Number of Participants With Stable Disease (SD) as Best Response (BR)', 'timeFrame': 'Up to 12 cycles of 3 weeks each', 'description': 'Stable disease included not meeting the criteria for MR or PD.'}, {'measure': 'Number of Participants With Stable Disease (SD) as Last Observed Response (LOR)', 'timeFrame': 'Up to 12 cycles of 3 weeks each', 'description': 'Stable disease included not meeting the criteria for MR or PD.'}, {'measure': 'Number of Participants With Progressive Disease (PD) PD as Best Response (BR)', 'timeFrame': 'Up to 12 cycles of 3 weeks each', 'description': 'PD includes one or more of the following criteria: \\>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation, \\>25% increase in 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 hr and confirmed on a repeat investigation, \\>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%., Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas, Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture), Development of hypercalcemia (corrected serum calcium \\>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).'}, {'measure': 'Number of Participants With Progressive Disease (PD) PD as Last Observed Response (LOR)', 'timeFrame': 'Up to 12 cycles of 3 weeks each', 'description': 'PD includes one or more of the following criteria: \\>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation, \\>25% increase in 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 hr and confirmed on a repeat investigation, \\>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%., Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas, Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture), Development of hypercalcemia (corrected serum calcium \\>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).'}, {'measure': 'Time to Disease Progression', 'timeFrame': 'From Day 1 till disease progression (approximately 12 cycles of 3 weeks each)', 'description': 'Time to disease progression was defined as the time from first dose until objective tumor progression. Participants who did not experience tumor progression were censored at their last known date in the study. It was estimated using Kaplan-Meier methodology. Participants who did not experience tumor progression were censored at their last known date in the study. The first quartile for time to disease progression was evaluated when 25th percentile of participants of mITT population reported disease progression. Similarly, median and 75th percentile of participants of MITT population was planned to be reported. If, less than 75th percentile of participants reported disease progression at the end of the study period, then the observation was censored for the purpose of this analysis and in such case the data was planned to be reported as not evaluable (NA).'}, {'measure': 'Change From Baseline in Hematology: White Blood Cell (WBC) Count, Neutrophils, Lymphocytes, Platelets', 'timeFrame': 'Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)', 'description': 'Blood samples collected to evaluate the hematology parameters were WBC count, neutrophils, lymphocytes and platelets. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.'}, {'measure': 'Change From Baseline in Hematology: Hematocrit', 'timeFrame': 'Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)', 'description': 'Blood samples were collected to evaluate the hematology parameter hematocrit. Change from Baseline was defined as the value of baseline minus from the End of study visit. Baseline was defined as Day 1.'}, {'measure': 'Change From Baseline in Hematology: Hemoglobin', 'timeFrame': 'Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)', 'description': 'Blood samples were collected to evaluate the hematology parameter hemoglobin. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.'}, {'measure': 'Change From Baseline in Hematology: Red Blood Cell (RBC)', 'timeFrame': 'Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)', 'description': 'Blood samples were collected to evaluate the hematology parameter RBC. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.'}, {'measure': 'Change From in Baseline Biochemistry: Serum Creatinine, Total Bilirubin', 'timeFrame': 'Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)', 'description': 'Blood samples were collected to evaluate hematology parameters serum creatinine and total bilirubin. Change from Baseline was defined as the value of baseline minus from the End of study visit. Baseline was defined as Day 1.'}, {'measure': 'Change From Baseline in Biochemistry -Urea, Bicarbonate', 'timeFrame': 'Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)', 'description': 'Blood samples were collected to evaluate the biochemistry parameter urea and bicarbonate. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.'}, {'measure': 'Change From Baseline in Biochemistry: Prothrombin Time (PT)/ International Normalized Ratio (INR)', 'timeFrame': 'Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)', 'description': 'Blood samples were collected to evaluate the biochemistry parameter PT/INR. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.'}], 'secondaryOutcomes': [{'measure': 'Plasma Concentrations of SRT501 at Indicated Time Points', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 2 and Cycle 1 Day 20 at pre-dose, 30 minute, 1 hour, 2 hour, 4 hour, 6 hour and 24 hour post-dose. Day 2 and Day 20, samples collected post-dose. Each cycle duration was 21 days.', 'description': 'Pharmacokinetic sampling on Day1/2 and Day 20/21 of Cycle 1 for participants ready to participate was planned. The sampling was planned to be collected at timepoints on Cycle 1 Day 1 at pre-dose, 30 minute, 1 hour, 2 hour, 4 hour, 6 hour and 24 hour post-dose and the same timepoints on Day 2 and Day 20 post- dose. It was to be collected in participants who fasted atleast for an hour. Due to early termination of the study, the data for Pharmacokinetic analysis was not collected.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'referencesModule': {'availIpds': [{'id': '113222', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113222', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113222', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113222', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113222', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113222', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '23205612', 'type': 'DERIVED', 'citation': 'Popat R, Plesner T, Davies F, Cook G, Cook M, Elliott P, Jacobson E, Gumbleton T, Oakervee H, Cavenagh J. A phase 2 study of SRT501 (resveratrol) with bortezomib for patients with relapsed and or refractory multiple myeloma. Br J Haematol. 2013 Mar;160(5):714-7. doi: 10.1111/bjh.12154. Epub 2012 Dec 4. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine the safety and tolerability of SRT501 (5.0 g) with or without concurrent bortezomib administration, when administered once daily in 21 day cycles, in male and female subjects with Multiple Myeloma.\n\nThe purpose is also to define objective response (ORR, CR, PR, MR, SD) and time to progression (TTP) of SRT501 with or without concurrent bortezomib administered concurrently in male and female subjects with Multiple Myeloma.\n\nIn addition, 15 subjects will participate in a sub-study to assess the pharmacokinetics of SRT501.', 'detailedDescription': 'This is an, open-label, phase II study of SRT501, alone or in combination with bortezomib, in subjects with measurable Multiple Myeloma. Sixty-one (61) evaluable subjects, who fulfill the inclusion/exclusion criteria, will be enrolled in this study. Pharmacokinetic (PK) samples will be collected from a subset of 15 subjects to determine SRT501 plasma concentrations in this patient population. Subjects will sign the informed consent form prior to any study related procedures. If eligible, subjects will receive 5.0 g of SRT501 to be administered for 20 consecutive days in a 21 day cycle for a maximum of 12 cycles. SRT501 will be administered as an oral suspension product at the same time each morning (approximately 15-30 minutes following consumption of breakfast) on all dosing days. Safety assessments will be performed continuously throughout the cycle and these will be reviewed for all subjects at Day 21 of each cycle prior to subjects proceeding to the next cycle. SRT501 will not be administered on Day 21 of each cycle. Subjects will be assessed for efficacy and response of SRT501 at the end of every 2 cycles (6 weeks) of treatment. When necessary, a bone marrow biopsy and CT (or appropriate radiographic imaging) of the chest and abdomen/pelvis will be performed to confirm response. After the first two cycles of SRT501 treatment and review of the efficacy and response analysis, any subject who exhibits stable disease or better with SRT501 monotherapy may continue on SRT501 monotherapy (5.0 g/day) for an additional two cycles. If, after the first two cycles of SRT501 monotherapy, a subject exhibits PD, then that subject will receive bortezomib (1.3 mg/ m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with SRT501 (5.0 g/day). Bortezomib will be administered prior to SRT501 administration. If after two additional cycles of SRT501 monotherapy (4 cycles total), the subject exhibits a MR or better, they will remain on SRT501 (5.0 g/day) treatment until they are judged to have SD or PD. At the time the subject is judged to have SD or PD after receiving at least four cycles of SRT501 (5.0 g/day) monotherapy, then they may also receive bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing. If at any point while a subject is receiving SRT501 and bortezomib the subject is assessed to have PD, then they will be removed from the study and will be required to undergo End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must be male or female ≥ 18 years at the time of signing Informed Consent.\n* Subject was previously diagnosed with Multiple Myeloma and has failed at least one prior treatment regimen for the disease.\n* Subject must have measurable disease.\n* Subjects must have relapsed or relapsed/refractory disease as defined in Appendix 4.\n* Subject must have a life expectancy of greater than 6 months.\n* Subject has an ECOG Performance status of 0 to 2 (Appendix 2).\n* Subject has no prior history of HIV-1, HIV-2, Hepatitis B or C infection.\n* Subject has a normal 12 lead ECG or an ECG with an abnormality considered to be clinically insignificant.\n* Subject has the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.\n* Subject must be able to adhere to the study visit schedule and other protocol requirements.\n* Subject must understand and voluntarily sign an informed consent document.\n* All subjects of reproductive potential must agree prior to study entry to use adequate contraception (hormonal or double barrier method of birth control; abstinence) for the duration of the study dosing and at least 12 weeks after completion of study drug.\n* Adequate end organ function, defined as the following:\n\n * Total bilirubin \\< 2 x ULN, unless attributable to Gilbert's disease\n * ALT (SGPT) and AST (SGOT) \\< 2.5 x ULN\n * Creatinine \\< 2.0 x ULN\n * ANC \\> 0.5 x 10\\^9/L\n * Platelets \\> 20,000 cells/mm3\n\nExclusion Criteria:\n\n* Intolerance to resveratrol, SRT501 or bortezomib or significant allergy to either compound, boron or mannitol or significant prior toxicity with either agent that would preclude the safe use of that agent. Prior therapy with either compound is permitted.\n* Subjects with other active malignancy, with the exception of basal cell or squamous cell carcinoma of the skin.\n* An uncontrolled intercurrent illness including, but not limited to, recent (≤ 6 months), ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, acute diffuse infiltrative pulmonary or pericardial disease, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Subject with a history of or current gastro-intestinal diseases influencing drug absorption, with the exception of an appendectomy.\n* Women who are breast-feeding, pregnant, expect to become pregnant during the course of the study, or are sexually active in a heterosexual relationship and are not using a medically acceptable double barrier method birth control. Confirmation that the subject is not pregnant must be established by a negative serum beta-hCG pregnancy test result obtained during the Screening period. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Women relying solely on oral contraceptives for birth control are excluded.\n* Subjects who have had chemotherapy or radiotherapy within 4 weeks prior to signing Informed Consent or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n* Subjects who are on any concurrent medications that may exhibit anti-neoplastic therapy, with the exception of \\< 10 mg of prednisone or equivalent as indicated for other medical conditions, or up to 100 mg of hydrocortisone as premedication for administration of certain medications or blood products.\n* Subjects currently taking any investigational therapies and/or dietary supplements containing resveratrol.\n* Subjects with peripheral neuropathy of Grade 2 or greater.\n* Subjects with uncontrolled bleeding.\n* Subjects with evidence of mucosal or internal bleeding and/or platelet refractory (i.e., unable to maintain a platelet count ≥ 20,000 cells/mm3).\n* Subjects with a hemoglobin \\< 8.0 g/dL. Transfusions and/or EPO treatment are permitted in subjects who are potentially excluded by this criteria.\n* Any condition, including laboratory abnormalities, that in the opinion of the Investigator, would preclude treatment."}, 'identificationModule': {'nctId': 'NCT00920556', 'briefTitle': 'A Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination With Bortezomib in Patients With Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase II, Open-Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination With Bortezomib in Patients With Multiple Myeloma', 'orgStudyIdInfo': {'id': '113222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': '5.0 g SRT501 will be administered for 20 consecutive days in a 21 day cycle for a maximum of 12 cycles. SRT501 will be administered at the same time each morning (approximately 15-30 minutes after breakfast) on all dosing days. No SRT501 administration will occur on Day 21 of each cycle.\n\nAfter the first two cycles of SRT501, any subject who exhibits stable disease or better with SRT501 monotherapy (5.0 g/day) will continue for an additional two cycles. If, after the first two cycles, a subject exhibits PD, that subject will receive bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with SRT501. Bortezomib will be administered prior to breakfast and SRT501 administration.\n\nIf after two additional cycles of SRT501 monotherapy (4 cycles total), the subject exhibits a MR or better, they they will remain on SRT501 therapy. If PD or SD are exibited, they are to undergo bortezomib regiment listed above.', 'interventionNames': ['Drug: 5.0g SRT501', 'Drug: Bortezomib']}], 'interventions': [{'name': '5.0g SRT501', 'type': 'DRUG', 'description': '5.0g SRT501 will be supplied in clinical kits as a powder which will be reconstituted with vehicle and water into a liquid suspension. SRT501 will be administered orally as a liquid suspension for 20 consecutive days in each 21 day cycle.', 'armGroupLabels': ['Treatment']}, {'name': 'Bortezomib', 'type': 'DRUG', 'description': 'Bortezomib (1.3 mg/m2) will be given as an intravenous solution in a 3-5 second push on Day 1, 4, 8 and 11 in every 21 day cycle.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7100', 'city': 'Vejle', 'country': 'Denmark', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'zip': 'SM2 5NG', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'EC1A 7BE', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sirtris, a GSK Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}